IPS CaseDesigner

K161634 · Nobel Biocare AB · LLZ · Nov 10, 2016 · Radiology

Device Facts

• Record ID: K161634
• Device Name: IPS CaseDesigner
• Applicant: Nobel Biocare AB
• Product Code: LLZ · Radiology
• Decision Date: Nov 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

Device Story

IPS CaseDesigner is a 3D image-based software tool for virtual planning of orthognathic surgery. Input consists of patient CBCT/CT data (DICOM). Surgeons use the software to plan osteotomies (Le Fort I, Sagittal Split, Ramus, Chin) by virtually cutting and repositioning bone fragments in 3D space. The software provides 2D/3D visualization, measurement tools, and soft tissue simulation to predict post-operative appearance. Output includes surgical splint order files sent to a manufacturing facility for production of patient-specific surgical aids. Used by oral and maxillofacial surgeons in clinical settings to facilitate surgical planning and improve patient outcomes through precise, individualized surgical guidance.

Clinical Evidence

No clinical data. Substantial equivalence supported by software verification and validation testing conducted in accordance with FDA guidance for software contained in medical devices.

Technological Characteristics

Software-based surgical planning tool; runs on Windows 64-bit and Mac platforms. Inputs: DICOM CT/CBCT data, generic 3D models (STL). Functions: 2D/3D visualization, distance/angle measurement, bone fragment manipulation (translation/rotation), soft tissue simulation, and surgical splint order file generation. Standalone software application.

Indications for Use

Indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner (e.g., CT) to support diagnostic and treatment planning for cranio-maxillofacial procedures, including orthognathic surgery.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Maxilim (K052424)
• Surgicase Orthognathic Software Wizard (K111641)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10, 2016

Nobel Biocare Ab % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K161634

Trade/Device Name: IPS CaseDesigner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 19, 2016 Received: October 20, 2016

Dear Charlemagne Chua:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Robert Oals

Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| Indications for Use |

| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |

| 510(k) Number (if known) | K161634 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | IPS CaseDesigner |
| Indications for Use (Describe) | IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids. |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| FORM FDA 3881 (1/14) | Page 1 of 1 |
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# 1. 510(k) Summary

### I. Submitter

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: [phone] x7830 Fax: [phone]

Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Date Prepared : October 19, 2016

# II. Device

Name of Device: IPS CaseDesigner Common or Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ

# III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate

- Maxilim, Medicim NV, K052424 ●
Additional Predicates

- Surgicase Orthognathic Software Wizard, Materialise N.V., K111641 ●

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# IV. Device Description

The IPS CaseDesigner software is a tool for the virtual planning of orthognathic surgery. The user is a (oral and maxillofacial) surgeon who needs to plan an orthognathic surgery, and will use the software to plan the osteotomy (bone cutting). This allows the surgeon to re-position the digitally cut pieces in the desired alignment and allows the visualization of how the patient aspect will look like, through soft tissue simulation. The software supports various types of osteotomy procedures (Le Fort I, Sagittal Split, Ramus and Chin).The selection of the appropriate osteotomy procedure for each patient case is at the discretion of the clinician.

The IPS CaseDesigner is a 3D image-based environment that allows the clinician to visualize a patient's anatomy. The creation of the 3D augmented patient model is derived from CBCT (Cone-Beam CT) data (DICOM). This allows the clinician virtually plan and simulate a craniomaxillofacial surgery. The IPS CaseDesigner software has the capability to save a surgical splint file that the clinician can send to the manufacturing facility for surgical splint creation based on the CBCT Data. The software does not have any functionality for designing.

# V. Indications for Use

IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

#### Discussion

The Indications for Use statement between the subject and predicate devices are equivalent; minor differences in wording do not alter the intended therapeutic use of the subject device nor do they affect the safety and effectiveness of the subject device relative to the predicate. Both the subject and predicate devices are software devices intended for the transfer of medical images and to support diagnostics and treatment planning of cranio-maxillofacial procedures.

#### VI. Comparison of Technological Characteristics

The subject and predicate devices are software based surgical planning tools which allow for transfer of medical images, and creation of 3D models.

A comparison of the subject and predicate devices is provided in the table below.

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| | SUBJECT DEVICE | PRIMARY PREDICATE | ADDITIONAL<br>PREDICATE |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IPS CaseDesigner | Maxilim<br>(K052424) | SurgiCase, SurgiCase CMF,<br>ProPlan CMF<br>(K111641) |
| Indications<br>for Use<br>Statement | IPS CaseDesigner is<br>indicated for use as a<br>software and image<br>segmentation system for the<br>transfer of imaging<br>information from a scanner<br>such as a CT scanner. It is<br>also indicated to support the<br>diagnostic and treatment<br>planning process of cranio-<br>maxillofacial procedures.<br>IPS CaseDesigner facilitates<br>the service offering of<br>individualized surgical aids. | Maxilim is indicated for use<br>as a software interface and<br>image segmentation system<br>for the transfer of imaging<br>information from a medical<br>scanner such as a CT<br>scanner. It is also indicated<br>for use as a planning and<br>simulation software for<br>surgical treatment,<br>specifically maxillofacial<br>procedures. | SurgiCase contains software<br>module for pre-operative<br>simulation of orthognathic<br>surgical treatment options,<br>based on imaging<br>information from a medical<br>scanner such as a CT scanner<br>or a Magnetic Resonance<br>Imaging (MRI) scanner. |
| Intended use | IPS CaseDesigner is a<br>software for the transfer and<br>visualization of imaging<br>information from equipment<br>such as a CT scanner to<br>support the diagnostic and<br>treatment planning process<br>in cranio-maxillofacial<br>regions. IPS CaseDesigner<br>facilitates the service<br>offering of individualised<br>surgical aids. | Maxilim is indicated for use<br>as a software interface and<br>image segmentation system<br>for the transfer of imaging<br>information from a medical<br>scanner such as a CT<br>scanner. It is also indicated<br>for use as a planning and<br>simulation software for<br>surgical treatment,<br>specifically maxillofacial<br>procedures. | Information not available |
| Clinical Use | Cranio-maxillofacial and<br>orthognathic treatment | Maxillofacial treatment | Cranio-maxillofacial and<br>Orthognathic treatment |
| Image Import | DICOM data format from<br>CT/ CBCT scanner<br>3D models in generic open<br>file format (STL) | DICOM data format from<br>CT/ CBCT scanner | CT/CBCT or MRI scan data |
| Software<br>Functions | 2D and 3D Visualization<br>Measuring tool,<br>Distance and angle | 2D and 3D Visualization<br>Measuring tool,<br>Distance and angle | 2D and 3D Visualization<br>Measuring tool |
| | SUBJECT DEVICE | PRIMARY PREDICATE | ADDITIONAL<br>PREDICATE |
| | IPS CaseDesigner | Maxilim<br>(K052424) | SurgiCase, SurgiCase CMF,<br>ProPlan CMF<br>(K111641) |
| | Bone fragments can be<br>moved in the 3D space<br>(translations and rotations) in<br>order to plan the ideal post-<br>operative position of each<br>fragment. | Bone fragments can be<br>moved in the 3D space<br>(translations and rotations) in<br>order to plan the desired<br>post-operative position of<br>each fragment. | Information not available |
| | 3D Surgical Model creation | 3D Surgical Model creation | 3D objects from medical<br>image data |
| | Soft tissue simulation | Soft tissue simulation and<br>3D photo mapping | Soft tissue simulation and<br>3D photo mapping |
| | Based on the created<br>orthognathic plan the user<br>can export surgical splint<br>order files. These files can<br>be used to calculate and<br>produce orthognathic splints<br>in the production backend | No | Patient-specific surgical<br>splints can be generated to<br>transfer the planned dental<br>occlusion to surgery. |
| Computer<br>System<br>Requirements | Windows 64bit,<br>Mac | Windows 32 or 64 bit. | Windows 64 bit. |

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#### Performance Data VII.

The following performance data were provided or relied upon in support of the substantial equivalence determination.

# Software Validation

Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

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# VIII. Conclusion

Although there are minor differences in the indications for use statements and technological features of the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the subject device is substantially equivalent to the cited predicate devices.